Clinical Trials Logo
  1. Home
  2. Stage III Rectal Cancer AJCC v8
  3. NCT05245786

An Investigational Scan (64Cu-Labeled M5A Antibody) in Combination With SOC Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer

Locally Advanced Rectal Carcinoma Clinical Trial

Official title:
Pilot Study: Imaging Tumor Extent and Response Before and After Neoadjuvant Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer Using 64Cu-Labeled M5A Antibody to Carcinoembryonic Antigen (CEA)

Clinical Trial Summary

This early phase I trial investigates how well 64Cu-labeled M5A antibody scan works in assessing tumor activity before and after patients with rectal cancer that has spread to nearby tissue or lymph nodes (locally advanced) who are undergoing chemotherapy and radiotherapy. Using 64Cu-labeled M5A positron emission tomography imaging may play a significant role in imaging patients with colorectal cancer.

Clinical Trial Description

PRIMARY OBJECTIVE: I. To determine if the Copper Cu 64 anti-carcinoembryonic antigen (CEA) monoclonal antibody M5A (64Cu labeled M5A antibody) demonstrates a potentially impactful finding for patient management either in the pre-treatment scan (potentially impacting choice of therapy or impacting the radiotherapy [RT] plan) or the scan immediately prior to planned surgery (after standard care [SOC] chemoradiation) in patients with locally advanced rectal cancer. SECONDARY OBJECTIVES: I. To determine the safety of administration of 64Cu labeled M5A antibody. II. To describe/summarize each of the 15 patients' 64Cu-M5A positron emission tomography (PET) imaging findings and corresponding SOC scans and pathology. OUTLINE: Patients receive 64Cu labeled M5A antibody intravenously (IV) over 5 minutes on day 0 pre standard of care chemo/radiotherapy and on day 0 post chemo/radiotherapy. Patients also undergo 64Cu-M5A PET scan on day 1 pre chemo/radiotherapy and on day 1 post chemo/radiotherapy. After completion of the study treatment, patients medical records are reviewed up to 2-3 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05245786
Study type Interventional
Source City of Hope Medical Center
Contact
Status Recruiting
Phase Early Phase 1
Start date August 31, 2022
Completion date November 12, 2025
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05920928 - Comparison of the Clinical Response of Total Neoadjuvant Treatment of Two Methods of Long-term or Short-term Chemoradiotherapy in Rectal Cancer N/A
Completed NCT06314737 - Assessment of Efficacy of Neoadjuvant Therapy in Locally Advanced Rectal Cancer
Recruiting NCT05524012 - Longitudinal Multimodal Response Assessment During Neoadjuvant Treatment of Rectal Cancer
Recruiting NCT05601505 - Circulating Tumor DNA-guided Neoadjuvant Treatment Strategy for Locally Advanced Rectal Cancer Phase 2
Recruiting NCT05876026 - MRI T1 Relaxation Time in Rectal Cancer
Completed NCT05622357 - Prospective Study of Short Course Radiation Therapy Followed by Neoadjuvant Chemotherapy and Surgery in Locally Advanced Rectal Cancer Phase 2
Terminated NCT04406857 - Testing the Addition of a Radiation Sensitizing Drug, IPdR, to the Usual Chemotherapy Treatment (Capecitabine) During Radiation Therapy for Rectal Cancer Phase 1
Not yet recruiting NCT06292975 - Exercise for Improving Radiotherapy Efficacy in Rectal Cancer N/A
Not yet recruiting NCT06276686 - Exercise for Improving Long-course Chemoradiotherapy Efficacy in People With Locally Advanced Rectal Cancer N/A
Recruiting NCT05591534 - Endorectal Brachytherapy for Rectal Cancer Phase 2
Recruiting NCT05722288 - Time-Restricted Eating Versus Nutritional Counseling for the Reduction of Radiation or Chemoradiation Tx Side Effects in Patients With Prostate, Cervical, or Rectal Cancers Phase 2
Not yet recruiting NCT05645094 - Neoadjuvant Envafolimab in Resectable and Locally Advanced MSI-H/dMMR Rectal Cancer
Active, not recruiting NCT06314750 - Deep Learning Based MRI Radiomics in Predicting the Clinical Risk of Locally Advanced Rectal Cancer
Recruiting NCT05731726 - Serplulimab Combined With CAPEOX + Celecoxib as Neoadjuvant Treatment for Locally Advanced Rectal Cancer Phase 2
Recruiting NCT06312982 - A Series of Neoadjuvant Chemoradiotherapy Combined With Immunotherapy for Locally Advanced Rectal Cancer: From a Multicenter Phase II Cohort to a Phase III Randomized Controlled Study Phase 2/Phase 3
Recruiting NCT04703101 - Short Course Radiation Therapy and Combination Chemotherapy for the Treatment of Stage II-III Rectal Cancer Phase 1
Recruiting NCT05610163 - Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage Rectal Cancers to Improve the Rate of Complete Response and Long-Term Rates of Organ Preservation Phase 2
Terminated NCT03280277 - Ferumoxytol-Enhanced MRI in Imaging Lymph Nodes in Patients With Locally Advanced Rectal Cancer Early Phase 1
Recruiting NCT05772923 - Organ Preservation in Rectal Cancer: Contact X-ray Brachytherapy vs Extending the Waiting Interval and Local Excision N/A
Recruiting NCT05792735 - Neoadjuvant Cadonilimab Plus Chemotherapy Following Short-Course Radiotherapy in Locally Advanced Rectal Cancer Phase 2